(P22-11-26) Comparative Effectiveness of Lipid-Nutrient Spread Supplementation Regimens for Moderate Acute Malnutrition: An Individually Randomized Non-Inferiority Trial

Objectives: Moderate acute malnutrition (MAM) affects over 30 million children globally and increases risk of morbidity and mortality. In 2023, the World Health Organization recommended either ready-to-use supplementary food (RUSF) or ready-to-use therapeutic food (RUTF) for children requiring supplementation for MAM. However, evidence comparing products and dosing strategies remains limited. We evaluated whether one- and two-sachet daily RUTF dosing are non-inferior to the de facto standard of one RUSF sachet daily.

Methods: We conducted a three-arm, parallel, individually randomized controlled trial (1:1:1) in Ethiopia. Children aged 6–59 months with MAM (MUAC 11.5–12.4 cm or WHZ < –2 and ≥ –3, without edema) were randomized to one sachet of RUSF/day (1-RUSF), one RUTF/day (1-RUTF), or two RUTF/day (2-RUTF). Both RUTF arms were evaluated for non-inferiority to 1-RUSF using a prespecified 6-percentage-point margin. The primary outcome was recovery (MUAC ≥ 12.5 cm and WHZ ≥ -2 for two consecutive visits within 16 weeks). Risk differences were estimated with 95% confidence intervals under an intention-to-treat analysis.

Results: Of 2,496 randomized children, 2,414 were analyzed. Recovery was 84.8% (679/801) for 1-RUSF, 85.0% (674/793) for 1-RUTF, and 88.1% (721/818) for 2-RUTF. Risk differences relative to 1-RUSF were +0.2 percentage points (95% CI –3.3 to 3.7) for 1-RUTF and +3.4 percentage points (95% CI 0.0 to 6.7) for 2-RUTF; both met non-inferiority criteria. Anthropometric gains and median length of stay (56 days) were similar. Product use was comparable for 1-RUSF and 1-RUTF; 2-RUTF required 1.6-fold more product.

Conclusions: One- and two-sachet daily RUTF were non-inferior to one RUSF for MAM supplementation. Although two RUTF sachets yielded slightly higher recovery, the incremental benefit was modest relative to increased product use. Given comparable outcomes between one RUTF and RUSF, either may be considered effective, with choice guided by supply and operational considerations.

Funding Sources: Funded by a consortium through the Power of Nutrition (Eleanor Crook Foundation, Rotary International, END Fund) with additional support from Action Against Hunger USA.